Vivax Malaria Human Infection Studies in Thailand
This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P. vivax-infected blood for use in future controlled human P. vivax malaria infection studies. Additional objectives are to obtain da
| Condition(s) | Plasmodium Vivax Infection |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P. vivax-infected blood for use in future controlled human P. vivax malaria infection studies. Additional objectives are to obtain data on host immune response to P. vivax infection and pre-treatment gametocytaemia. This study is funded by the UK Wellcome Trust. The grant reference number are Oxford/MORU: 212336/Z/18/Z and 212336/Z/18/A, and Mahidol University: 212336/A/18/Z and 212336/A/18/A. |
| Who can participate | Inclusion Criteria: * Healthy adult aged 20 to 55 years with weight more than 50 kg. * Blood group O. * Red blood cells positive for the Duffy antigen/chemokine receptor (DARC). * CYP2D6 alleles consistent with normal metaboliser status * Normal blood levels of Glucose-6-phosphate dehydrogenase (G6PDH) by the WHO definition. * COVID-19 vaccination at least two doses of COVID-19 vaccine(s) approved by WHO. * Agree to practice continuous effective contraception for the duration of study period until 3 months post-challenge. * Agreement to refrain from blood donation during the course of the study and for 1 year after the end of their involvement in the study. * Willing to take a curative antimalarial regimen following challenge. * Willing to be admitted in the Hospital for Tropical Diseases |
| Ages | 20 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Oxford |
| Locations | Bangkok, Thailand |
| Start date | 2020-10-05 |
| NCT ID | NCT04083508 |
| Official listing | https://clinicaltrials.gov/study/NCT04083508 |